Joshua Weinger
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Articles by Joshua Weinger
Year In Review: Top Legal Developments Of 2024
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year's recap of 2023, Regeneron's litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Year in Review: Top Legal Developments of 2024
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year’s recap of 2023, Regeneron’s litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Year in Review: Top Legal Developments of 2024
As 2024 has come and passed, we saw another year of significant developments in litigation involving biologics and biosimilars. The following is a recap of the top four legal developments that we covered on the Big Molecule Watch last year. The Aflibercept BPCIA Litigations Continue Into 2025 As was the case with last year’s recap of 2023, Regeneron’s litigation against multiple aflibercept biosimilar competitors tops our chart this year.
Preliminary Injunction Denied Against Amgen In Aflibercept BPCIA Litigation
In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. Based on alleged infringement of U.S. Patent No. 11,084,865 ("'865 patent"), Regeneron had requested a preliminary injunction that would prevent Amgen from launching PAVBLU (aflibercept-ayyh), Amgen's biosimilar of Regeneron's EYLEA®. The FDA approved PAVBLU on August 23, 2024.
Preliminary Injunction Denied Against Amgen in Aflibercept BPCIA Litigation | JD Supra
In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. Based on alleged infringement of U.S. Patent No. 11,084,865 (“’865 patent”), Regeneron had requested a preliminary injunction that would prevent Amgen from launching PAVBLU (aflibercept-ayyh), Amgen’s biosimilar of Regeneron’s EYLEA®. The FDA approved PAVBLU on August 23, 2024.
Preliminary Injunction Denied Against Amgen in Aflibercept BPCIA Litigation
In a sealed order that issued on September 24, 2024, the District Court for the Northern District of West Virginia denied a preliminary injunction against Amgen in the aflibercept BPCIA litigation. Based on alleged infringement of U.S. Patent No. 11,084,865 (“’865 patent”), Regeneron had requested a preliminary injunction that would prevent Amgen from launching PAVBLU (aflibercept-ayyh), Amgen’s biosimilar of Regeneron’s EYLEA®. The FDA approved PAVBLU on August 23, 2024.
Recent PTAB Developments for Regeneron’s Aflibercept-Dosing Patents | JD Supra
There have been several recent developments in the PTAB with respect to Regeneron’s aflibercept-dosing patents. On July 8, Regeneron voluntarily dismissed its appeals to the Federal Circuit (Case Nos. 2023-1395 and 2023-1396) of six IPR final written decisions, finding claims of U.S. Patent Nos. 9,669,069 and 9,254,338 unpatentable. The IPRs at issue were brought by Mylan (2021-00880 and 2021-00881), Celltrion (2022-00257 and 2022-00258), and Apotex (2022-00301 and 2022-00298).
Intellectual Property
There have been several recent developments in the PTAB with respect to Regeneron's aflibercept-dosing patents. On July 8, Regeneron voluntarily dismissed its appeals to the Federal Circuit (Case Nos. 2023-1395 and 2023-1396) of six IPR final written decisions, finding claims of U.S. Patent Nos. 9,669,069 and 9,254,338 unpatentable. The IPRs at issue were brought by Mylan (2021-00880 and 2021-00881), Celltrion (2022-00257 and 2022-00258), and Apotex (2022-00301 and 2022-00298).
Recent PTAB Developments for Regeneron’s Aflibercept-Dosing Patents
There have been several recent developments in the PTAB with respect to Regeneron’s aflibercept-dosing patents. On July 8, Regeneron voluntarily dismissed its appeals to the Federal Circuit (Case Nos. 2023-1395 and 2023-1396) of six IPR final written decisions, finding claims of U.S. Patent Nos. 9,669,069 and 9,254,338 unpatentable. The IPRs at issue were brought by Mylan (2021-00880 and 2021-00881), Celltrion (2022-00257 and 2022-00258), and Apotex (2022-00301 and 2022-00298).
Court Cancels Injunction Hearings In Aflibercept BPCIA Litigation; Regeneron May Seek Temporary Restraining Orders
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical's ("Regeneron") motion to establish a multi-district litigation ("MDL") for its aflibercept BPCIA litigation. Pursuant to that order, Regeneron's case against Amgen, Inc.
Cell Therapy Cos. Must Beware Limits Of Patent Safe Harbors
By Natasha Daughtrey and Joshua Weinger (May 15, 2024, 5:59 PM EDT) -- As of June 2023, there were over 3,500 advanced genetic therapies under active development.[1]... Law360 is on it, so you are, too. A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence. Over 200 articles are published daily across more than 60 topics, industries, practice areas and jurisdictions.
Court Cancels Injunction Hearings In Aflibercept BPCIA Litigation; Regeneron May Seek Temporary Restraining Orders | JD Supra
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation. Pursuant to that order, Regeneron’s case against Amgen, Inc.
Court Cancels Injunction Hearings In Aflibercept BPCIA Litigation; Regeneron May Seek Temporary Restraining Orders
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation. Pursuant to that order, Regeneron’s case against Amgen, Inc.
Goodwin Releases Update To Its Comprehensive Guide To Biosimilars Litigation And Regulation In The U.S.
Global law firm Goodwin today announced the release of the 2023-2024 annual update to its definitive biosimilars treatise Guide to Biosimilars Litigation and Regulation in the U.S. The Guide, first launched in 2019, is the industry's first and leading compendium of the laws and regulations governing biosimilars in the U.S., and is authored by a multidisciplinary team of experts drawn from Goodwin's Intellectual Property, Life Sciences, FDA, Antitrust + Competition, and Appellate Litigation...
Breaking: Judgment in Regeneron v. Mylan (aflibercept) BPCIA Case Finding Some Claims of Asserted Patents Valid and Infringed | JD Supra
As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. The patents-at-issue are directed to formulations and dosing regimens for aflibercept, an anti-VEGF treatment for retinal disorders including age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
Breaking: Judgment in Regeneron v. Mylan (aflibercept) BPCIA Case Finding Some Claims of Asserted Patents Valid and Infringed
As previously reported by Big Molecule Watch, trial in Regeneron’s BPCIA case against Biocon regarding Biocon’s proposed aflibercept biosimilar concluded on June 15, 2023 in the Northern District of West Virginia. The patents-at-issue are directed to formulations and dosing regimens for aflibercept, an anti-VEGF treatment for retinal disorders including age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
Formycon Announces FDA Acceptance of the aBLA for Its Aflibercept Biosimilar | JD Supra
On August 29, 2023, Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon’s candidate biosimilar to Regeneron’s EYLEA® (aflibercept).
Formycon Announces FDA Acceptance of the aBLA for Its Aflibercept Biosimilar
On August 29, 2023, Formycon AG and its licensing partner, Klinge Biopharma GmbH, announced that the FDA has accepted the aBLA for FYB203, Formycon’s candidate biosimilar to Regeneron’s EYLEA® (aflibercept).
Amgen Intervenes In Regeneron V. Mylan BPCIA Aflibercept Litigation To Seek Public Access To Sealed Documents
As we have previously reported, Regeneron's BPCIA case against Mylan regarding Mylan's proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial scheduled to begin on June 12, 2023.
Amgen Intervenes in Regeneron v. Mylan BPCIA Aflibercept Litigation to Seek Public Access to Sealed Documents | JD Supra
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial scheduled to begin on June 12, 2023.
New Patents Listed In The Purple Book For Regeneron's EYLEA
FDA's Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. As we previously reported, a patent list for Regeneron's EYLEA (aflibercept) was added to the Purple Book in April 2022. That original list contained 29 patents, including the 24 patents that Regeneron later asserted against Mylan in a BPCIA lawsuit filed in August 2022.
Amgen Intervenes in Regeneron v. Mylan BPCIA Aflibercept Litigation to Seek Public Access to Sealed Documents
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial scheduled to begin on June 12, 2023.
Amgen Intervenes in Regeneron v. Mylan BPCIA Aflibercept Litigation to Seek Public Access to Sealed Documents
Amgen, BPCIA, Litigation, Mylan, Public Access, Regeneron As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding in the U.S. District Court for the Northern District of West Virginia, with a two-week trial scheduled to begin on June 12, 2023.
New Patents Listed in the Purple Book for Regeneron’s EYLEA | JD Supra
FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. As we previously reported, a patent list for Regeneron’s EYLEA (aflibercept) was added to the Purple Book in April 2022. That original list contained 29 patents, including the 24 patents that Regeneron later asserted against Mylan in a BPCIA lawsuit filed in August 2022.
New Patents Listed in the Purple Book for Regeneron’s EYLEA
FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. As we previously reported, a patent list for Regeneron’s EYLEA (aflibercept) was added to the Purple Book in April 2022. That original list contained 29 patents, including the 24 patents that Regeneron later asserted against Mylan in a BPCIA lawsuit filed in August 2022.
Regeneron v. Mylan BPCIA Aflibercept Litigation Update: Claim Construction Order and Stipulation to Narrow the Case for June 2023 Trial | JD Supra
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023. On April 19, the Court issued a claim construction order construing seven terms from the claims of the four patents still being asserted in the case.
Regeneron v. Mylan BPCIA Aflibercept Litigation Update: Claim Construction Order and Stipulation to Narrow the Case for June 2023 Trial
As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023. On April 19, the Court issued a claim construction order construing seven terms from the claims of the four patents still being asserted in the case.
Regeneron v. Mylan BPCIA Aflibercept Litigation Update: Claim Construction Order and Stipulation to Narrow the Case for June 2023 Trial
Aflibercept, BPCIA, Eylea, Litigation, Mylan, Regeneron As we have previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023. On April 19, the Court issued a claim construction order construing seven terms from the claims of the four patents still being asserted in the case.
Regeneron v. Mylan - Update on Aflibercept BPCIA Litigation | JD Supra
As we previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a year from Regeneron’s filing of its complaint in August 2022. The Court’s scheduling order, issued in October 2022, required Regeneron to immediately identify six patents for the June trial from among the 24 patents originally listed in Regeneron’s Complaint.
Regeneron v. Mylan - Update on Aflibercept BPCIA Litigation
As we previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a year from Regeneron’s filing of its complaint in August 2022. The Court’s scheduling order, issued in October 2022, required Regeneron to immediately identify six patents for the June trial from among the 24 patents originally listed in Regeneron’s Complaint.
Regeneron v. Mylan - Update on Aflibercept BPCIA Litigation
As we previously reported, Regeneron’s BPCIA case against Mylan regarding Mylan’s proposed aflibercept biosimilar is proceeding on an expedited schedule, with a two-week trial scheduled to begin on June 12, 2023, less than a year from Regeneron’s filing of its complaint in August 2022. The Court’s scheduling order, issued in October 2022, required Regeneron to immediately identify six patents for the June trial from among the 24 patents originally listed in Regeneron’s Complaint.
Aflibercept IPRs Update | JD Supra
On March 10, 2023, the PTAB denied institution of IPR2022-1524, filed by Apotex Inc. regarding Regeneron’s Patent No. 11,253,572. As we previously reported, Apotex filed an IPR petition against the ’572 patent in September 2022, challenging claims that generally relate to methods for treating angiogenic eye disorders with a claimed dosing regimen of aflibercept.
FDA Approves Amgen's RIABNI™ (Rituximab-arrx) For Adults With Moderate To Severe Rheumatoid Arthritis
On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen's RIABNI (rituximab-arrx), a biosimilar to Genentech's RITUXAN®, in combination with methotrexate for treatment of moderate to severely active rheumatoid arthritis (RA).
FDA Approves Amgen’s RIABNI™ (Rituximab-arrx) for Adults With Moderate to Severe Rheumatoid Arthritis | JD Supra
On June 6, 2022, Amgen announced that the U.S. Food and Drug Administration has approved Amgen’s RIABNI (rituximab-arrx), a biosimilar to Genentech’s RITUXAN®, in combination with methotrexate for treatment of moderate to severely active rheumatoid arthritis (RA).
Regeneron’s Disclaimer of Aflibercept Formulation Patent Causes PTAB Denial of Institution of Celltrion PGR | JD Supra
On March 15, 2022, the Patent Trial and Appeal Board (PTAB) denied institution of post-grant review (PGR) proceedings initiated by Celltrion Inc. concerning Regeneron Pharmaceutical’s U.S. Patent No. 10,857,231 (the ’231 Patent) after Regeneron disclaimed the patent. The ’231 patent has claims directed to formulations of aflibercept, the active ingredient in Regeneron’s product Eylea, which is indicated for treatment of age-related macular degeneration and other ophthalmic disorders.
Celltrion Announces Agreement with Brazilian Government to Supply Infliximab Biosimilar | JD Supra
On March 24, 2022, Celltrion Healthcare announced that it had won a bid to the Brazilian Federal Government to supply a biosimilar version of Remsima® (infliximab), along with bids to 12 Brazilian states.
Celltrion Announces Agreement with Brazilian Government to Supply Infliximab Biosimilar
On March 24, 2022, Celltrion Healthcare announced that it had won a bid to the Brazilian Federal Government to supply a biosimilar version of Remsima® (infliximab), along with bids to 12 Brazilian states.
Enzene Biosciences Announced Romiplostim Approval in India | JD Supra
Last week, Enzene Biosciences announced that it has received marketing authorization from the Drug Controller General of India (DCGI) for its biosimilar product romiplostim. The product will be offered in three dosage strengths and is indicated for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults. ITP is a hematological disorder involving low platelet levels, with symptoms including increased tendencies for bruising and bleeding.
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